Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test

NCT04958109 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 2673395K23HD097296
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test

Conditions

Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

• Oral Glucose Sensitivity Index (Kisspeptin-Placebo)

  Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in oral glucose tolerance test

  3 hours

Study Arms (2)

Kisspeptin

EXPERIMENTAL

• Intravenous administration of kisspeptin 112-121 x 16 hours

Diagnostic Test: Oral Glucose Tolerance Test; Drug: Kisspeptin

Placebo

PLACEBO COMPARATOR

• Intravenous administration of placebo x 16 hours

Diagnostic Test: Oral Glucose Tolerance Test; Drug: Placebo

Interventions

Kisspeptin DRUG

Intravenous administration of kisspeptin 112-121 x 16 hours

Kisspeptin

Oral Glucose Tolerance Test DIAGNOSTIC_TEST

Administration of a 75 gm oral glucose tolerance test

Kisspeptin; Placebo

Placebo DRUG

Intravenous administration of Placebo 16 hours

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• History:
• over the age of 18,
• normal pubertal development
• stable weight for previous three months,
• normal body mass index (BMI between 18.5-25)
• regular menstrual cycles
• Physical examination:
• systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg
• Laboratory studies: (per Massachusetts General Hospital reference ranges)
• normal hemoglobin
• hemoglobin A1C \< 6.5%
• blood urea nitrogen, creatinine not elevated
• aspartate aminotransferase, alanine aminotransferase \< 3x upper limit of normal

You may not qualify if:

• active illicit drug use,
• history of a medication reaction requiring emergency medical care,
• difficulty with blood draws.
• history of chronic disease, except well controlled thyroid disease,
• recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug). Use of levothyroxine or seasonal allergy medications is acceptable,
• history of diabetes in a first degree relative,
• use of contraceptive pills, patches or vaginal rings within last 4 weeks.
• hyperlipidemia by fasting lipid panel
• positive serum pregnancy test (for all women)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Glucose Tolerance Test; Kisspeptins

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Neuropeptides; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins

Limitations and Caveats

This was designed as a pilot study

Results Point of Contact

• Title: Margaret Lippincott
• Organization: Massachusetts General Hospital

mlippincott@mgh.harvard.edu

6177268434

Study Officials

• Margaret Lippincott, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, Harvard Reproductive Endocrine Sciences Center

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 12, 2021
• Study Start: October 28, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: March 6, 2026
• Results First Posted: December 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)